MAC 3500 Ver 9B and C Operators Manual Rev E

The information in this manual applies only to MAC 3500 resting ECG analysis systems running software versions 9B or 9C. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MAC, MULTI-LINK, MUSE, MACTRODE, MobileLink, and 12SL are trademarks owned by GE Medical Systems Information Technologies, a General Electric Company going to market as GE Healthcare. All other marks are owned by their respective owners. © 2007-2008 General Electric Company. All rights reserved.

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CE Marking Information

CE Marking Information Compliance The MAC 3500 system bears the CE mark “CE-0459”, notified body GMED, indicating its conformity with the provisions of the Council Directive 93/42/EEC, concerning medical devices and fulfills the essential requirements of Annex I of this directive. Any other directive(s) and all the standards the product complies to are listed in the general information of the operator manual for the product following this page. The country of manufacture can be found on the equipment labeling. The safety and effectiveness of this device has been verified against previously distributed devices. Although all standards applicable to presently marketed devices may not be appropriate for prior devices (i.e. electromagnetic compatibility standards), this device will not impair the safe and effective use of those previously distributed devices.

Recommendations Users should be aware of known RF sources, such as radio or TV stations and hand-held or mobile two-way radios, and consider them when installing a medical device or system. Be aware that adding accessories or components, or modifying the medical device or system may degrade the EMI performance. Consult with qualified personnel regarding changes to the system configuration. Operating the system near radio frequency (RF) electromagnetic interference (EMI) above the conditions defined in the EMC Standard EN60601-1-2 for Radiated Immunity (field strengths above 3 volts per meter) may cause waveform distortions. Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying service manual. Portable and mobile RF communications equipment can affect medical electrical equipment. The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by the manufacturer of the system as replacement parts for internal components, may result in increased emissions or decreased immunity of the system. The system should not be used adjacent to or stacked with other equipment and that if adjacent to or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used.

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CE Marking Information

Review the AAMI Committee Technical Information Report (TIR) 18, “Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers”. This guidance document provides a means to evaluate and manage the EMI environment in the hospital. The following actions can be taken to reduce the risk of medical device EMI and achieve EMC:

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Assess the EMC environment of the healthcare facility (e.g., identify radio transmitters in around the facility) and identify areas where critical medical devices are used (e.g., ER, ICU, CCU, NICU).

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Increase the distance between sources of EMI and susceptible devices.

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Remove the devices that are highly susceptible to EMI.

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Lower power transmitted from electrical and electronic equipment (EMI sources) under hospital control (i.e. paging systems).

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Label devices susceptible to EMI.

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Educate healthcare facility staff (nurses and doctors) to be aware of, and to recognize, potential EMI related problems.

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Contents 1

Introduction Manual Information... 1-2 Purpose...1-2 Intended Audience...1-2 Revision History...1-2 Conventions... 1-3 Style...1-3 Product Reference...1-3 Safety Information... 1-3 Definitions...1-3 Classification...1-9 Underwriters Laboratories, Inc...1-10 Legal Notice...1-10 Responsibility of the Manufacturer...1-10 General Information... 1-10 Intended Use...1-10 Recording ECGs During Defibrillation...1-11 Accuracy Of the Input Signal Reproduction...1-11 Modulating Effects in Digital Systems...1-11 Installation and Connection...1-12 Parts and Accessories...1-12 Equipment Symbols...1-12 Service Information... 1-13 Service Requirements...1-13 Equipment Identification...1-14

2

Equipment Overview Equipment Description... 2-2 Front View...2-2 Side View...2-3 Back View...2-4 Internal View...2-5 Connectors... 2-6 Back Panel...2-6 Keyboard...2-7 Acquisition Module...2-8 Leadwire Adapters...2-9 Getting Started... 2-9 Prepare the Equipment for Use... 2-9 Modem Option...2-9 MobileLink Wireless Option...2-9

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LAN Option...2-9 Connect the Acquisition Module Cables...2-10 Verify Correct Operation...2-10 Software Description... 2-11 Start Up Screen...2-11 Main Menu...2-11 Main Menu Functions...2-12 Selecting Menu Functions...2-12 Pressing a Function Key...2-13 Using the Arrow Pad...2-13 Entering Data... 2-14 Type Data into a Highlighted Field...2-14 Selecting Items from a List...2-14 Configure the Device...2-15

3

Preparing the Patient Prepare the Patient’s Skin... 3-2 Apply the Electrodes... 3-3 Resting Electrodes...3-4

4

Entering Patient Information Enter Patient Information... 4-2 Using a Patient Card Reader (Option)... 4-2 Connect and Configure the Card Reader...4-2 Slide Card...4-3 Using a Bar Code Reader (Option)... 4-3 Connect and Configure the Bar Code Reader...4-3 Scan the Bar Code...4-3 Receive Orders from a MUSE System (Option)... 4-4 Preparation...4-4 Load the Orders...4-4 Select the Orders to Receive...4-5 Select an Order to Complete...4-5 Complete the Order...4-5 Enter Orders Manually (Option)... 4-5 Selecting and Completing Manually Created Orders... 4-5

5

Recording an ECG Hookup Advisor... 5-2

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Record a Resting ECG... 5-3 Record a Master’s Step Test (Option)... 5-4 Run the Test... 5-4

6

Printing an ECG Report Print Stored ECG Reports... 6-2 Print Another Report... 6-2

7

Transmitting an ECG Transmit Stored ECGs by Modem (Option)... 7-2 Transmit Stored ECGs Locally (Option)... 7-3 Transmit Stored ECGs by Wireless (Option)... 7-3 Transmit Stored ECGs to the Serial Port in XML Format... 7-4

8

Receiving an ECG Receive ECGs by Modem (Option)... 8-2 Receive ECGs Locally (Option)... 8-3

9

Deleting an ECG Delete Stored ECGs... 9-2 Delete Stored ECG Orders (Option)... 9-2

10

Editing an ECG Editing an ECG... 10-2 Edit Demographic and Interpretive Data...10-2 Enter the Overreader Password...10-2 Edit Resting Measurements...10-2 Edit Diagnostic Statements... 10-3 Insert or Append an Acronym...10-3 Insert or Append Free Text...10-3 Move a Statement to a New Line...10-3 Delete a Statement...10-3 Join Two Statements...10-3 Store the Edited ECG...10-4

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11

Completing Other Tasks Prepare a Secure Digital (SD) Card for Use... 11-2 Lock and Unlock...11-2 Format...11-2 Eject an SD Card From the Drive Slot... 11-2 File Manager... 11-2 Copy All (Option)...11-2 Restore All (Option)...11-3 Save XML...11-3 Print the ECG... 11-4 Display Measurement and Analysis Statements... 11-4 Return to the Main Menu... 11-4 Software Update From Secure Digital Card... 11-4

12

System Setup Using the System Setup Function... 12-2 Select the System Setup Function...12-2 Define the System Parameters...12-2 Save Your Changes...12-2 Program the System to Automatically Do a Task... 12-2 To Print a Resting ECG Report...12-2 Store an ECG...12-2 Transmit an ECG...12-3 Define the Basic System Setup... 12-3 Miscellaneous Setup...12-3 Patient Questions...12-6 Screen Colors...12-8 Transmission...12-8 Network Setup...12-9 Option Activation...12-10 Date and Time...12-11 Language...12-11 Power Up Options...12-11 Order Manager Interface...12-12 PS/2 Port...12-12 Define the ECG Setup... 12-13 ECG Acquisition...12-13 ECG Analysis...12-15 Patient Questions...12-16 Writer Setup...12-17

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Resting ECG Reports...12-17 Analog Outputs...12-19 CT Data Guard Setup...12-19 Card Reader Option Setup... 12-21 Automatic Configuration of Card Reader...12-21 Manual Configuration of Card Reader...12-22 Bar Code Reader Option Setup... 12-22 Automatic Configuration of Bar Code...12-22 Manual Configuration of Bar Code Reader...12-23 Creating Bar Codes and Magnetic Cards...12-23 Master’s Step Setup (Option)... 12-25 Miscellaneous Setup... 12-25 Print Setup...12-25 Save Setup...12-25 Restore Setup...12-26

A

Maintenance General... A-2 Inspecting and Cleaning... A-2 Precautions... A-2 Visual Inspection... A-2 Cleaning Exterior Surfaces... A-3 Cleaning, Disinfecting, and Storing ECG Cables and Leadwires... A-3 Cleaning/Disinfecting... A-3 Sterilization... A-4 Cautions... A-4 Storage... A-5 Improper Cleaning Products and Processes Impact/Results... A-5 Cleaning Products To Avoid... A-5 Paper... A-6 Changing the Paper Tray Size... A-6 Replacing Paper... A-7 Thermal Paper Storage... A-7 Archivist Paper Storage... A-8 Maintaining the Battery... A-8 Battery Gauge Icon... A-8 To Fully Charge the Battery... A-9 When Should You Charge the Battery?... A-9 Before Initial Use... A-9 Between Acquisitions... A-9 When the Battery is Low... A-9 When the Battery is Completely Discharged... A-10 Is the Battery Charging?... A-10

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Periodic Maintenance... A-10 Replacing the Battery... A-10 Replacing Acquisition Module Leadwire Adapters... A-11

B

Troubleshooting Introduction... B-2 First Things to Ask... B-2 Visual Inspection... B-2 Equipment Problems... B-2 Reducing ECG Data Noise... B-2 System Errors... B-3

C

Editing Acronyms Resting ECG Acronyms... C-2

D

Report Formats Format Description... D-2 4 by 2.5s + 1 Rhythm Lead Format... D-2 Additional Report Names... D-3

E

Master’s Step Data Master’s Step Table... E-2 ST-T Change... E-3

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Introduction

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Introduction

Manual Information Purpose This manual contains the instructions necessary to operate the system in accordance with its function and intended use.

Intended Audience This manual is intended for the person who uses, maintains, or troubleshoots this equipment.

Revision History The document number and revision appear at the bottom of each page. The following table describes the changes made with each revision. Revision History, PN 2021337-035

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Revision

Date

A

1 June 2006

Initial release of document.

B

24 July 2006

Added information about SD card recommended by GE.

C

14 September 2007

Revised Document Assembly Worksheet to add Hg Symbol Description Addendum to English and China only manual.

D

26 March 2008

Revised Document Assembly Worksheet to add RoHS addendum to English and Chinese manuals only.

E

31 October 2008

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Extended document to v9C software.

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Updated “Equipment Symbols.”

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Introduction

Conventions NOTE Provides additional user information.

Style Bold text

Indicates keys on the keyboard, text to be entered, or hardware items such as buttons or switches on the equipment.

Italicized text

Indicates software terms that identify menu items, buttons, or options in various windows.

Ctrl + Esc

Indicates a keyboard operation. A (+) sign between the names of two keys indicates that you must press and hold the first key while pressing then releasing the second key. For example, “Press Ctrl+esc” means to press and hold down the Ctrl key while pressing the Esc key.

[Space]

Indicates you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where the spacebar must be pressed is indicated as: [Space]. The purpose of the < > brackets is to ensure you press the spacebar when required.

Enter

Indicates you must press the “Enter” or “Return” key on the keyboard. Do not type “enter”.

Product Reference The product described in this manual is MAC 3500 Resting ECG Analysis System. It will be referred to as “the system” throughout this document.

Safety Information Definitions The terms danger, warning, and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with their definitions and significance. Hazard is defined as a source of potential injury to a person. DANGER indicates an imminent hazard which, if not avoided, will result in death or serious injury. WARNING indicates a potential hazard or unsafe practice which, if not avoided, could result in death or serious injury.

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Introduction CAUTION indicates a potential hazard or unsafe practice which, if not avoided, could result in minor personal injury or product/property damage. NOTE provides application tips or other useful information to assure that you get the most from your equipment. WARNING ACCIDENTAL SPILLS - If liquids have entered a device, take it out of service and have it checked by a service technician before it is used again. To avoid electric shock or device malfunction liquids must not be allowed to enter the device.

WARNING BATTERY OPERATION - If the integrity of the protective earth conductor is in doubt, operate the unit from its battery.

WARNING CABLES - To avoid possible strangulation, route all cables away from patient's throat.

WARNING CONNECTION TO MAINS - This is class I equipment. The mains plug must be connected to an appropriate power supply.

WARNING DEFIBRILLATOR PRECAUTIONS - Do not come into contact with patients during defibrillation. Otherwise, serious injury or death could result. Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages. To ensure proper defibrillator protection, use only the recommended cables and leadwires. Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation.

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Introduction

WARNING ELECTRODES - Polarizing electrodes (stainless steel or silver constructed) may cause the electrodes to retain a residual charge after defibrillation. A residual charge will block acquisition of the ECG signal. Whenever patient defibrillation is a possibility, use nonpolarizing (silver/silver chloride construction) electrodes for ECG monitoring.

WARNING MAGNETIC AND ELECTRICAL INTERFERENCE - Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment or MRI devices are possible sources of interference as they may emit higher levels of electromagnetic radiation.

WARNING EXPLOSION HAZARD - Do NOT use in the presence of flammable anesthetics vapors or liquids.

WARNING INTERPRETATION HAZARD - Computerized interpretation is only significant when used in conjunction with clinical findings. A qualified physician must overread all computergenerated tracings.

WARNING OPERATOR - Medical technical equipment such as this system must only be used by qualified and trained personnel.

WARNING TREADMILLS - Avoid rapid changes in treadmill speed and/or grade during a stress test.

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Introduction

WARNING SITE REQUIREMENTS - Do not route cables in a way that they may present a stumbling hazard. For safety reasons, all connectors for patient cables and leadwires are designed to prevent inadvertent disconnection, should someone pull on them. For devices installed above the patient, adequate precautions must be taken to prevent them from dropping on the patient.

WARNING SHOCK HAZARD - Improper use of this device presents a shock hazard. Strictly observe the following warnings. Failure to do so may endanger the lives of the patient, the user, and bystanders. When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord. Devices may be connected to other devices or to parts of systems only after making certain that there is no danger to the patient, the operators, or the environment as a result. Standards IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.

CAUTION ACCESSORIES (SUPPLIES) - To ensure patient safety, use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies. Parts and accessories used must meet the requirements of the applicable IEC 60601 series safety standards and essential performance standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard.

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Introduction

CAUTION PROPER LEADWIRE CONNECTION - Improper connection will cause inaccuracies in the ECG. Trace each individual leadwire from its acquisition module label to the colored connector and then to the proper electrode to ensure that it is matched to the correct label location.

CAUTION ACCESSORIES (EQUIPMENT) - The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: Use of the accessory in the PATIENT VICINITY; and Evidence that the safety certification of the ACCESSORY has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard.

CAUTION BATTERY POWER - If a device equipped with an optional battery pack will not be used or not be connected to the power line for a period of over six months, remove the battery.

CAUTION BEFORE INSTALLATION - Compatibility is critical to safe and effective use of this device. Please contact your local sales or service representative prior to installation to verify equipment compatibility.

CAUTION DISPOSABLES - Disposable devices are intended for single use only. They should not be reused as performance may degrade or contamination could occur.

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Introduction

CAUTION DISPOSAL - At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. If you have questions concerning disposal of the product, please contact GE or its representatives.

CAUTION EQUIPMENT DAMAGE - Devices intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site. Wait until all moisture has vaporized before using the device.

CAUTION ELECTRIC SHOCK - To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel.

CAUTION OPERATOR - Medical technical equipment such as this electrocardiograph system must only be used by persons who have received adequate training in the use of such equipment and who are capable of applying it properly.

CAUTION POWER REQUIREMENTS - Before connecting the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit's label. If this is not the case, do not connect the system to the power line until you adjust the unit to match the power source. In the U.S.A., if the installation of this equipment will use 240V rather than 120V, the source must be a centertapped, 240V, single-phase circuit. This equipment is suitable for connection to public mains as defined in CISPR 11.

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CAUTION RESTRICTED SALE - U.S. federal law restricts this device to sale by or on the order of a physician.

CAUTION SERVICEABLE PARTS - This equipment contains no user serviceable parts. Refer servicing to qualified service personnel.

CAUTION SUPERVISED USE - This equipment is intended for use under the direct supervision of a licensed health care practitioner.

Classification The unit is classified, according to IEC 60601-1, as:

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Type of protection against electrical shock

Class I internally powered equipment

Degree of protection against electrical shock

Type BF defibrillation-proof applied part

Degree of protection against harmful ingress of water

Ordinary Equipment (enclosed equipment without protection against ingress of water)

Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Method(s) of sterilization or disinfection recommended by the manufacturer

Not applicable

Mode of operation

Continuous operation

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Introduction

Underwriters Laboratories, Inc. Medical Equipment With respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1, and CAN/CSA C22.2 NO. 601.1. 4P41

Legal Notice Our equipment contains several fields which can be filled in before performing an ECG. Some of these fields must be filled in before performing an exam, some are optional and therefore left to the user to assess whether they are needed to perform the exam. A field RACE is one of these optional fields. It has been acknowledged by the medical profession as useful to analyze some pathologies. You should be aware that, in some jurisdictions, the processing of data revealing an individual’s racial origin is subject to legal requirements, such as obtaining the patient’s prior consent. If you elect to collect this type of data, it is your responsibility to ensure that you comply with all applicable legal requirements.

Responsibility of the Manufacturer GE is responsible for the effects of safety, reliability, and performance only if: „

Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE.

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The electrical installation of the relevant room complies with the requirements of the appropriate regulations.

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The equipment is used in accordance with the instructions for use.

General Information Intended Use The intended use of this device is to record ECG signals from surface ECG electrodes. This device can record, analyze, print, and store electrocardiographic information from adult and pediatric populations. This data can then be computer analyzed with various algorithms such as interpretive ECG for presentation to the user. This device is intended for use under the direct supervision of a licensed health care practitioner. This device is not intended for use with high frequency surgical units. Disconnect the patient from the device before using the high frequency surgical unit.

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